New User Fees Set for Foreign Medical Device Manufacturers in China
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
CFDA registration fees will not be insubstantial: Imported Class II device registrants will be charged about $34,000 for initial registration, while foreign Class III device registrants will have to pay about $49,000 for initial registration. Registration renewals every five years for imported devices will cost registrants $6,500 per renewal. User fees will be charged in addition to in-country testing, clinical trials, authorized representation and translation costs.
A translation of the draft fee table below does not include any potential fees for Class I CFDA record filing or CFDA quality system audits.
| CFDA Medical User Fees | |||||
|---|---|---|---|---|---|
| Unit: Chinese Yuan (RMB) | Unit: US Dollars (USD) | ||||
| Domestic | Imported | Domestic | Imported | ||
| Class II | Initial Registration | - | 210,900 | - | 33,761 |
| Variation Application | - | 42,000 | - | 6,723 | |
| Renewal every 5 years) | - | 40,800 | - | 6,531 | |
| Class III | High Risk MD Clinical Trial Approval | 43,200 | 43,200 | 6,915 | 6,915 |
| Initial Registration | 153,600 | 308,800 | 24,588 | 49,433 | |
| Variation Application | 50,400 | 50,400 | 8,068 | 8,068 | |
| Renewal (every 5 years) | 40,800 | 40,800 | 6,531 | 6,531 | |
Emergo consultants and partners in China will continue monitoring the Medical User Fee issue and its impact on foreign firms with devices registered for sale in the country.
Original Post: New User Fees Set for Foreign Medical Device Manufacturers in China
Related Post: Further Analysis of New Chinese Medical Device Registration Requirements
Related Post: Further Details on Revised Chinese Authorized Representation, Clinical Evaluation Requirements